Director External Quality LM EMEA

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

Essential Job Duties and Responsibilities

General Objectives

The function provides QA oversight for multiple External Manufacturers in the EMEA region.

Act as a coach and mentor for (Sr.) Managers, contractors, consultants, and Associates.

The position provides leadership to a team of Quality Assurance professionals supporting strategic manufacturing projects in the EMEA region.

Contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical products.

The position requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.

Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues.

Position requires travel to External Manufacturer's sites to provide cGMP assistance and quality oversight.

Specific Objectives


* Provide Quality Assurance, compliance and technical oversight to a portfolio of large molecule Drug Product and Drug Substance manufacturers in the EMEA region.


* Drive a culture of continuous improvement across a group of external manufacturers.

Develop, monitor and effectively utilize dashboards, control charts and quality indicators and take action to correct those situations which are not in line with established controls or targets.

Lead the development of corrective action plans and monitor implementation.


* Ensure that all relevant QA related concerns at the external manufacturing sites are


* raised to Janssen management.

Ensure that the manufacturing operations for Janssen at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.


* Provide leadership to a team of Senior EQ Account Managers for the management of strategic projects and key accounts.


* Ensure that personnel are recruited and trained to support activities in line with business needs


* Build and continue to develop a strong, solid, cohesive team within EQ LM EMEA.


* Continue to develop a High Performing Credo based Culture with direct reports and across wider EQ team in which every associate is valued and recognized for their contribution to our success.


* Provide strategic quality direction to colleagues in PES and MSAT, more specifically, in view of the business development projects, NPI and site transfers.


* As a memb...